Description:
This role is responsible for conducting quality testing activities on pharmaceutical products in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates testing results in terms of accuracy and precision against predetermined specifications to ensure product integrity and regulatory compliance. The position identifies ongoing quality issues and takes proactive measures to prevent potential production problems, contributing to continuous quality improvement. It applies various measuring devices, testing equipment, and prescribed methodologies to accept or reject products based on defined quality criteria. The role audits and monitors testing processes and outputs against both internal and regulatory standards to uphold compliance. It tests random samples of finished goods to verify conformance with quality specifications and regulatory expectations. The position reports testing process deviations and defects in finished goods to the appropriate quality and production stakeholders. It supports the organization's commitment to delivering safe, effective, and compliant pharmaceutical products through rigorous quality testing.
Essential Functions:
- Perform quality testing activities on pharmaceutical products in accordance with established specifications and regulatory requirements.
- Interpret and evaluate testing results for accuracy and precision against predetermined quality standards.
- Identify ongoing quality issues and implement preventive measures to avoid potential production disruptions.
- Operate various measuring devices and testing equipment using predetermined methods and prescribed specifications to accept or reject products.
- Audit and monitor testing processes and outputs against defined internal and regulatory quality standards.
- Test random samples of finished goods to verify compliance with quality specifications.
- Report testing process deviations and defects in finished goods to relevant stakeholders in a timely manner.
- Contribute to process improvement initiatives by identifying opportunities to enhance quality testing processes and methodologies.
Maintain accurate and complete documentation of all quality testing activities in compliance with GMP and GLP requirements.
Additional Responsibilities:
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
